Evolution of Maternal and Paternal-fetus Attachment in Egg Donation

February 26, 2024 updated by: Fundación IVI

Assessing the Evolution of Maternal and Paternal-fetus Attachment in Couples Conceiving Through Egg Donation

Recently, many families have been formed through gamete donation, a reproductive treatment where the ensuing children do not share a genetic link with either parents. However, despite such an increase, little is known about the parent-child relationship. Indeed, only two longitudinal studies have provided scientific background about family functioning in gamete donation. These studies showed that in egg donation families, the parent-child relationship was normal for parenting, parent psychological health, and child adjustment.

A more recent study evaluated mother-infant interaction in egg donation families comparing them with those created through IVF with their own gametes. Data collected showed that in egg donation families the mother-infant relationship quality appeared to be less optimal. Mothers were less interactive and stimulating, and infants showed lower involvement and less responsiveness with respect to their mothers Overall, the evidence suggests that women conceiving through egg donation likely require a variable period of adaptation to parenting. Here, the investigators aim to evaluate this interaction at an earlier stage, that is during the gestation. The specific bond that parents develop towards the fetus during pregnancy is called "parental-fetus attachment". Previous studies showed that the quality of the parental-fetus attachment is predictive of the quality of the postnatal parent-infant relationship and the child development The purpose is to evaluate whether the lack of genetic link with their offspring could undermine the parental attachment to the fetus, comparing couples conceiving through egg donation with those who get pregnant through a standard IVF treatment with their own gametes. No studies have been performed so far on this matter.

To assess the mother-father fetus attachment, the investigators will administer standardized and validated questionnaires to couples undergoing IVF with their own gametes, or egg donation cycles. For women, the investigators will use the Maternal Antenatal Attachment Scale . For men, the investigators will use the Paternal Antenatal Attachment Scale (PAAS-IT) . Furthermore, to also assess the emotional status of both partners, the investigators will use the Matthey Generic Mood Questionnaire .

Seeing that in the general population the maternal-fetal attachment level increases once women have completed the principal prenatal genetic screenings (like NIPT, CVS or amnio) and once they start perceiving the fetal movements, the investigators will administer the same questionnaire twice: between the 19-23 weeks and between the 28-32 weeks of gestation. This approach will enable monitoring of the evolution of the maternal and paternal fetal attachment at relevant gestational time-points.

As a result of the knowledge gathered from this study, the investigators will be able to develop a specific intervention strategy to promote this fundamental process for egg donation families.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The reference population includes all couples who have become pregnant in the selected IVI RMA clinics , through egg donation or standard IVF treatment, being the woman 40 years old or above, with no other specific indications (except individuals taking psychotropic drugs). Their native language must be English or Italian.

Description

DONATED GAMETE GROUP

Inclusion criteria:

  • getting pregnant through an egg donation program
  • Own semen
  • Native language must be English or Italian

Exclusion criteria:

  • Patients failing to consent to be recontacted for research purpose.
  • Patients who are taking psychotropic drugs
  • Patients who got pregnant through sperm or embryo donation

OWN GAMETE GROUP

Inclusion criteria:

  • getting pregnant through a standard IVF treatment with own gametes
  • Native language must be English or Italian

Exclusion criteria:

  • Patients failing to consent to be recontacted for research purpose.
  • Patients who are taking psychotropic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DONATED GAMETE GROUP
couples who got pregnant through egg donation (with their own semen)
Other: Questionnaires
Questionnaires
OWN GAMETE GROUP
couples who got pregnant through standard IVF treatment, with their own gametes
Other: Questionnaires
Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
validated questionnaire to assess the change of maternal fetus attachment (MAAS)
Time Frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
The MAAS total score is calculated by the sum of all item of the questionnaire, and the subscales score (quality and intensity of the attachment) are calculated through the sum of the rate of each item that is included in that scale. Scoring is 1-5, with 5 high attachment
between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
validated questionnaire to assess the change of Paternal fetus attachment (PAAS)
Time Frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
The PAAS total score is calculated by the sum of all item of the questionnaire, and the subscales score (quality and intensity of the attachment) are calculated through the sum of the rate of each item that is included in that scale. Scoring is 1-5, with 5 high attachment
between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
questionnaire to explore the change of the Emotional status (Anxiety or depression feelings) during pregnancy (MGMQ)
Time Frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
The MGMQ provideds a screen positive / negative classification of emotional distress
between 19-23 gestational weeks and follow up between 28-32 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación IVI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 4, 2024

Study Completion (Estimated)

December 4, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2112-ROM-108-MF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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